Wiki Head CT Choice Study: Adaptation of US Two Decision Aids to a Québec Local Context

Not Applicable

• Conditions: Decision-making; Mild Traumatic Brain Injury; Emergencies
• Interventions: Device: Real-life clinical meetings

• Registration Number: NCT04140084
• Lead Sponsor: Laval University

Brief Summary

This study aims to adapt two decision aids (DAs) (pediatric and adult) developed in the United States to the Quebec context to develop context-adapted tools and training program that will facilitate the process of shared decision-making while taking a decision to use head computed tomography (CT scan) with patients suffering from a mild traumatic brain injury.

Detailed Description

Background: Mild traumatic brain injury (mTBI) is among the most common neurological conditions with an estimated annual incidence rate of 450 to 650/100,000 in Canada. Head computed tomography (CT) scans are used as the reference standard test to rule out life-threatening complications, such as intracranial hemorrhage, but present potential exposition risks for the patient. Despite the use of clinical decision rules (Canadian Head CT Rule; Pediatric Head Injury/Trauma Algorithm (PECARN)), head CTs remain overused. Two decision aids (pediatric and adult) developed in the United States (U.S.) may help reduce the use of CTs for mTBI.

The goal of this study is to address the challenges of adapting two existing decision aids to local contexts. Stakeholders, including patients, or parents of patients, will be involved in adapting and validating the two existing decision aids to a local context and to create a training program about shared decision-making (SDM) in trauma care.

Objectives:

1. Translate two decision aids for head CTs (pediatric and adult) developed in the United States and adapt them to the Quebec context;

2. Create training for Emergency Medicine professionals on adopting decision aids with mTBI patients;

3. Measure the appropriate use of CTs in two hospitals(CHU de Sainte-Justine, Hotel-Dieu de Levis) before implementing the tools.

Methods:

Phase 1 will be the translation and adaptation of two decision aids to support decision-making about performing a head CT for adult and pediatric mTBI using an iterative user-centered approach. (Translation of the decision aids on the use of CT scans for mTBI (pediatric and adult) produced in the United States; simple ethnographic observation of the interactions of emergency health professionals and mTBI patients to understand the needs of patients, family members and health professionals in deciding to conduct a head CT for mTBI patients for the redesign of the tools; rapid prototyping of our different decision aids using interviews and real-life clinical encounters.)

Phase 2 will be the development of a training session for healthcare professionals.

Phase 3 will be a retrospective analysis of medical records to evaluate the use of head CT for mTBI patients in two hospitals (pediatric and adult).

Expected results:

This study will adapt two decision aids to the context of trauma care in Quebec and create a training program about shared decision-making and decision aids in the context of the care of mTBI patients. The final content and user interface of the decision aid/training session will be influenced by the multiple comments received from the participants in this study. This novel online and in -person training program will be instrumental in implementing our novel decision aid in practice. The results generated from the implementation of the intervention will help other centers in Quebec, Canada and abroad use the educational program and decision aid. The results of this research project will contribute to the enhancement of many research fields such as the involvement of end- users in the development process of decision aids. This research project will offer new learning opportunities for graduate students to study how collaboration among multiple stakeholders can improve patient outcomes and how to develop patient- centered tools that respond to their needs and those of the clinicians that care for them. Finally, this project will advance our understanding of the use of shared decision-making and decision aids in the field of trauma care.

Study Timeline

• Study Start: 2018-11-15
• Status Verified: 2019-10
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25
• Primary Completion: 2020-02-15
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Real-life clinical meetings	Real-life clinical meetings	This step will include a presentation of the tools to 5 emergency physicians so that they can use the tools with patients (5 adults, 5 parents of pediatric patients) in a realistic setting to identify any problems of use. The clinicians and patients that had used the tools during the clinical encounters will be then met during cognitive interviews to collect their comments on the tools and to address any usability issues. A final revision of the prototypes is scheduled at the end of this step.

Primary Outcome Measures

Name	Time	Method
Adapting two decision aids to the context of trauma care in Quebec.	interviews or departmental meeting or clinical encounters with participants over a duration of one year	Adapting two decision aids to the context of trauma care in Quebec using interviews of 5 adult patients and 5 parents of pediatric patients and 2 focus group (during departmental meeting), as well as real-life medical encounters with 5 adult patients and 5 pediatric patients (and parents).
Create a training program about SDM in the context of the care of mTBI patients.	meetings over a 3 months periods	Create a training program about SDM in the context of the care of mTBI patients with specialists using the data and comments gathered during the rapid prototyping phase.
Understand CT scan overuse in two hospitals.	retrospective analysis during a year (10 hours/week)	Understand CT scan overuse in two hospitals, one pediatric and one general hospital, by looking at health records (randomized samples).

Trial Locations

Locations (1)

Centre integre de sante et de services sociaux de Chaudiere-Appalaches; 🇨🇦 Levis, Quebec, Canada